• NBN EN ISO 15883-1 : 2009 AMD 1 2014

    Current The latest, up-to-date edition.

    WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)

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    Language(s): 

    Published date:  12-01-2013

    Publisher:  Belgian Standards

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
       4.1 General
       4.2 Cleaning
       4.3 Disinfection
       4.4 Rinsing
       4.5 Drying
       4.6 Process chemicals
    5 Mechanical and process requirements
       5.1 Materials, design and manufacture/construction
       5.2 Safety
       5.3 Calorifiers and tanks
       5.4 Loading and unloading doors and their controls
       5.5 Pipework and fittings
       5.6 Spray systems
       5.7 Dosing systems
       5.8 Load temperature protection
       5.9 Process temperature control limits
       5.10 Switches, gauges and indicating devices
       5.11 Process verification
       5.12 Instrumentation and controls
       5.13 Temperature indicating systems
       5.14 Pressure indicating systems
       5.15 Timing equipment
       5.16 Operating cycle indicating equipment
       5.17 Recording instruments (if fitted)
       5.18 Control systems
       5.19 Override of automatic control
       5.20 Microprocessor control systems
       5.21 Access to software
       5.22 Fault indication systems
       5.23 Water supply
       5.24 Venting and drainage systems
       5.25 Drainage
       5.26 Air filters installed within the WD
       5.27 Load handling and supports for use within the WD
       5.28 Trolleys
       5.29 Environment
    6 Testing for conformity
       6.1 General
       6.2 Test equipment
       6.3 Tests on doors, interlocks and fault indications
       6.4 Tests on water quality and water volume
       6.5 Tests on pipework
       6.6 Tests on instrumentation fitted to the WD
       6.7 Tests on load carriers
       6.8 Thermometric tests
       6.9 Chemical dosing tests
       6.10 Tests of cleaning efficacy
       6.11 Tests of air quality
       6.12 Load dryness test
       6.13 Automatic control test
    7 Documentation
    8 Information to be supplied by the manufacturer
       8.1 General
       8.2 Before delivery of the WD and for installation
       8.3 At delivery of the WD
    9 Marking, labelling and packaging
       9.1 Marking and labelling
       9.2 Packaging
    10 Information to be requested from the purchaser by the
       supplier of the WD
    Annex A (informative) - Test programme
    Annex B (informative) - A[0] concept - Comparative lethality of
            moist heat processes
    Annex C (normative) - Test methods for the detection and
            assessment of residual proteinaceous contamination
    Annex D (normative) - Microbiological recovery medium for
            estimation of bacterial contamination of water
    Annex ZA (informative) - Relationship between this European
                              Standard and the Essential Requirements
                              of EU Directive 93/42/EEC on medical
                              devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

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    Document Type Standard
    Publisher Belgian Standards
    Status Current
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